A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Part of paid clinical trials in Arcadia, California.

Sponsor
Sanofi
Study ID
NCT06834347
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itepekimab (SAR440340) — DRUG
    Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
  • Placebo — DRUG
    Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
  • Mometasone furoate nasal spray (MFNS) — DRUG
    Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray

Study Details

EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.

Key Dates

Start date
Feb 12, 2025
Status verified
May 2026
Primary completion
Oct 14, 2026
Completion
Sep 16, 2027

Study Design

Enrollment
231 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Itepekimab high dose
    Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks
  • Experimental: Itepekimab low dose
    SC administration of Itepekimab low dose for 52 weeks
  • Placebo Comparator: Placebo
    SC administration of matching placebo for 52 weeks

Primary Outcome Measure

Change from baseline in the endoscopic NPS [ Time Frame: Baseline to Week 24 ]

Locations (21)

FacilityCityStateZIPSite coordinators
University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037ArcadiaCalifornia91006-
Sensa Health- Site Number : 8400038Los AngelesCalifornia90006-
Newport Native MD- Site Number : 8400031Newport BeachCalifornia92663-
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400064RosevilleCalifornia95661-
Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040TorranceCalifornia90503-
Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035TorranceCalifornia90505-
Advanced Research Associates (ARA) Professionals- Site Number : 8400011MiamiFlorida33176-
Paradisus Med Research - Miami- Site Number : 8400009MiamiFlorida33185-
Orlando ENT Associates - Orlando- Site Number : 8400008OrlandoFlorida32807-
Emory University School of Medicine- Grady Campus- Site Number : 8400047AtlantaGeorgia30303-
Treasure Valley Medical Research- Site Number : 8400063BoiseIdaho83706-
University of Chicago Medical Center- Site Number : 8400018ChicagoIllinois60637-
Deaconess Clinic Allergy East- Site Number : 8400056EvansvilleIndiana47715-
SSM Health Saint Louis University Hospital- Site Number : 8400005St LouisMissouri63104-
Northwell Health Physician Partners Rheumatology at Great Neck- Site Number : 8400028Great NeckNew York11021-
Essential Medical Research- Site Number : 8400066TulsaOklahoma74137-
TEN20 Clinical Research - Dallas- Site Number : 8400015DallasTexas75244-
Houston Methodist Hospital- Site Number : 8400054HoustonTexas77030-
ENT Associates of Texas - McKinne- Site Number : 8400062McKinneyTexas75070-
Alamo ENT Associates- Site Number : 8400065San AntonioTexas78258-
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400046NorfolkVirginia23510-

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University of Southern California (USC) / Keck Medicine of USC· Arcadia, CASensa Health· Los Angeles, CANewport Native MD· Newport Beach, CASacramento Ear Nose & Throat - Roseville· Roseville, CABreathe Clear Institute of Sinus and Allergy Relief· Torrance, CAOrso Health - Torrance - Hawthorne Boulevard· Torrance, CA

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